Pectoralis Minor Release Versus Non-release in RSA

Rotator Cuff Tear Arthropathy Clinical Trial

Official title:

A Randomized Control Trial to Evaluate Release Versus Non-release of Pectoralis Minor With Reverse Shoulder Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06292169
• Other study ID #: STUDY00007201
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Emory University
• Contact: Eric Wagner, MD
• Phone: 404-778-7249
• Email: eric.r.wagner[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to assess if concomitant open pectoralis minor release would improve pain and outcomes after Reverse Shoulder Arthroplasty (RSA). The main questions it aims to answer are: - whether releasing the pectoralis minor prophylactically could have better pain relief - whether releasing the pectoralis minor prophylactically could have increased Range of motion (ROM) outcomes - whether releasing the pectoralis minor prophylactically could have higher final Patient Reported Outcome Measurements (PROMs) Participants will be randomized to either undergo RSA with pectoralis minor release or RSA without pectoralis minor release.

Description:

Shoulder arthroplasty has been increasing at exponential rates, particularly due to the rise of reverse shoulder arthroplasty (RSA). Postoperative complications after RSA include infection, instability, hardware component loosening, acromial and scapular spine fractures, neurologic injury, and scapular notching which can all cause pain. However, despite excluding these causes, some patients can have persistent anterior shoulder pain with poor motion. RSA prostheses work by translating the center of rotation (COR) inferiorly and medially, which increases tension on the deltoid, which is thought to increase the deltoid's mechanical moment arm and thus its ability to abduct and flex the humerus. However, excessive lengthening may be a cause of acromial and scapular spine fractures or neurologic injury. In addition, other structures are tensioned, including the conjoint tendon (short head of the biceps brachii and coracobrachialis) and pec minor (PM). It is unclear if lengthening these muscle-tendon units has functional consequences or whether it can create an intrinsic pathology. It is therefore feasible that muscle lengthening could create tendinitis, which could lead to persistent anterior shoulder pain after RSA. In addition, excessive tension or over-activity in the PM is also known to be a cause of altered scapula biomechanics. Good scapula biomechanics after RSA are critical to preserving an impingement-free range of motion, which is important in maximizing postoperative outcomes, implant longevity, and preventing component loosening and instability. However, it is known from the non-arthroplasty population that during repetitive movements with scapular protraction, a hyperactive or spasming PM shortens and develops contracture, leading to protracted resting scapular position and altered scapular contribution to shoulder range of motion.1 This causes altered scapular kinematics, or dyskinesia, and alters scapular accommodation to shoulder motion, a well-known feature in various shoulder pathologies. This can be a major problem after RSA when scapula accommodation is critical to ROM and function. Due to the expendability of the pectoralis minor, its release would cause minimal functional detriment in non-pathological cases, but in cases of overactivity, release could markedly improve scapula biomechanics. This can be performed open or arthroscopically, but the concomitant open release would be straight-forward at the time of the index surgery through the same incision

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing surgery for reverse total shoulder arthroplasty
• Patients willing and able to provide informed consent

Exclusion Criteria:

• Revision arthroplasty
• Reverse shoulder arthroplasty for proximal humerus fractures
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Related Conditions & MeSH terms

• Reverse Total Shoulder Arthroplasty
• Rotator Cuff Injuries
• Rotator Cuff Tear Arthropathy

Intervention

Procedure:
• Pectoralis Minor Release
The pectoralis minor is a muscle on the anterior chest wall attaching to the coracoid process. In the group undergoing pectoralis minor release, through the same deltopectoral incision that will not be extended or different as compared to the RSA only group, the pec minor will be exposed on the medial aspect of the coracoid at the upper part of the incision. It will be cut from its insertion on the coracoid while being careful to protect any neurovascular structures.
• RSA
RSA is the current Standard of Care (SOC)

Locations

Country	Name	City	State
United States	Emory Clinic	Atlanta	Georgia
United States	Emory Healthcare Orthopaedics and Spine Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual analog Scale (VAS) pain scores	The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Study participants will be asked to rate their current level of pain by placing a mark on the line	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
Other	American Shoulder and Elbow Score (ASES)	The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points.	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
Other	Subjective Shoulder Value (SSV)	Subjective Shoulder Value is study participant's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
Other	Change in Range of motion (ROM)	ROM is calculated in terms of angles. Lower number suggests restricted motion.	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
Other	Change in Scapulohumeral Rhythm (SHR) on Digital Dynamic Radiography (DDR)	SHR is the ratio of humeral abduction over the change in scapula upward rotation during humeral abduction. This SHR will be captured on Digital Dynamic Radiography (DDR) and reported as a change in SHR before and after the interventions.	Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
Other	Number of complications	Number of complications post intervention would be measured.	1 year
Other	Number of reoperations	Number of reoperations following intervention would be measured.	1 year
Primary	Visual analog Scale (VAS) pain scores	The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Study participants will be asked to rate their current level of pain by placing a mark on the line	Baseline, 6 months